Omeza Complete Matrix for Foot Ulcer

Not yet recruiting at 2 trial locations

Overseen By Sarah Moore

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Omeza, LLC

Must be taking: Oral glycemic, Insulin

Must not be taking: Immunosuppressants, Cytotoxic chemotherapy

Disqualifiers: Malignancy, Uncontrolled disorders, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding the Omeza Complete Matrix (OCM) to standard care for diabetic foot ulcers can speed up healing. Individuals with diabetes and a foot ulcer present for at least four weeks without significant healing may qualify. The trial compares standard care alone to standard care combined with OCM, which uses fish collagen to aid wound healing. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance healing for diabetic foot ulcers.

Is there any evidence suggesting that the treatments in this trial are likely to be safe?

Research shows that Omeza Complete Matrix (OCM) is safe for treating wounds like diabetic foot ulcers. Studies have found that OCM also treats other types of ulcers, such as leg and pressure ulcers. Data indicate that patients tolerate it well. In some cases, patients experienced high rates of wound healing, highlighting its potential effectiveness and safety for diabetic foot ulcers. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for foot ulcers?

Unlike the standard of care for foot ulcers, which involves methods like surgical debridement and offloading, the Omeza® Complete Matrix (OCM™) is unique because it utilizes hydrolyzed fish collagen derived from whitefish skin. This innovative ingredient is designed to enhance wound healing by providing a natural scaffold for new tissue growth. Researchers are excited about OCM™ because it could offer a more effective and potentially faster healing process for foot ulcers compared to existing treatments.

What evidence suggests that the Omeza Complete Matrix is effective for diabetic foot ulcers?

Research has shown that the Omeza Complete Matrix (OCM), which participants in this trial may receive, can help heal diabetic foot ulcers. One study found that patients using OCM had their wounds close by 90 to 100 percent within 12 weeks. This treatment uses a special type of fish collagen that may help the skin heal more effectively. In this trial, using OCM alongside standard care aims to improve wound healing. These promising results suggest OCM could be effective in treating diabetic foot ulcers. ^{1 2 4 5 6}

Who Is on the Research Team?

Angelina Ferguson, DNP

Principal Investigator

SygNola, LLC

Are You a Good Fit for This Trial?

Adults with Type I or II Diabetes and a diabetic foot ulcer present for 4 weeks to less than 12 months, showing little healing. The ulcer must be Wagner grade 1-3 without infection or visible bone (grade 3 allowed if acute osteomyelitis is treated). Ulcers should measure between 0.7cm² and 25cm², have been offloaded for two weeks, and show good circulation.

Inclusion Criteria

I am 18 years old or older.

I have diabetes and take medication or insulin to manage it.

I have had a diabetic foot ulcer for more than 4 weeks but less than 12 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard of care (SOC) alone or SOC plus OCM for up to 12 weeks. Crossover subjects in the SOC arm may switch to SOC plus OCM after 84 days if criteria are met.

12 weeks

Weekly visits

Crossover Treatment

SOC arm subjects not achieving complete wound closure may cross over to receive SOC plus OCM with weekly applications for up to 12 treatment visits.

12 weeks

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including tracking of adverse events and wound re-opening.

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Omeza® Complete Matrix

Trial Overview The trial compares standard diabetic foot ulcer care alone versus the same care plus OCM™ (Omeza® Complete Matrix) treatment. It aims to see if adding OCM improves complete healing of ulcers by the end of the study.

How Is the Trial Designed?

Group I: OCM + SOC Experimental Treatment 1 Intervention

Omeza® Complete Matrix (OCM™) is a wound care matrix comprised of hydrolyzed fish collagen derived from whitefish skin

Group II: Standard of Care Active Control 1 Intervention

Surgical sharp debridement, offloading (TCC gold standard, fixed ankle-walker alternative), and proper moisture balance

Who Is Running the Clinical Trial?

Omeza, LLC

Lead Sponsor

Trials

7

Recruited

370+

SygNola, LLC

Industry Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07161830

NCT07161830 | Evaluating the Efficacy of OCM™ (Omeza ... This study aims to compare two treatment approaches for diabetic foot ulcers (DFUs): the standard of care (SOC) alone versus SOC combined with OCM.

2. omeza.com omeza.com/case-studies-of-patients-with-diabetic-foot-ulcers-showed-90-to-100-percent-wound-closure-at-12-weeks-following-weekly-treatment-with-novel-omeza-ocm/

Case Studies of Patients with Diabetic Foot Ulcers Showed ... ... Omeza® OCM™ demonstrated 90 to 100 percent wound closure at 12 weeks. ... The current data on OCM™ were collected by the Jobst Vascular ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05417425

Omeza Products in Combination With Standard of Care for ... This study is to evaluate the efficacy of OCM™ used in combination with off-loading devices for the treatment of diabetic foot ulcers. Detailed Description. The ...

4. mearis.cms.gov mearis.cms.gov/public/publications/device-ptp/DEP2403016HWP6

OMEZA Complete Matrix OCM - DEP2403016HWP6 - MEARIS The age of wounds healed ranged from 12 weeks to 15 years. Wounds treated include diabetic foot, venous leg ulcers, pressure injuries, arterial, pyoderma, ...

5. ohsu.edu ohsu.edu/sites/default/files/2021-04/OMEZA%20Protocol%20Final%20Version%205.0_2.10.2021.pdf

The Omeza Protocol for Chronic Ulcers This study will compare the Omeza® Products Bundle to standard of care (SOC) in subjects with chronic venous leg ulcers and subjects with diabetic foot ulcers.

6. omeza.com omeza.com/novel-omeza-ocm-wound-healing-platform-combined-with-offloading-in-patients-with-diabetic-foot-ulcers-demonstrated-dramatic-healing-rates-within-12-weeks-or-less-2/

NOVEL OMEZA® OCM™ WOUND HEALING PLATFORM ... PAR is considered a surrogate endpoint of complete wound healing, with a PAR of 50 percent at four weeks in diabetic wound patients considered a ...